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To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral DIM (Active agent) | Experimental | 2mg/kg/day po of DIM |
|
| Red rice bran (Placebo) | Active Comparator | this agent is not generally thought to be active but may be |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| di indolylmethane (DIM) | Drug | This is the agent being studies. Similar agents have been reported to have potential activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure the regression of CIN in women by cytology, colposcopy, and biopsy, | To determine if oral DIM is effective in promoting the regression of CIN in women | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HPV colonization by commercial ELIZA test | To correlate the response to DIM with HPV colonization | 3 months |
| Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20 | To assess for any adverse effects of oral DIM in women |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Del Priore, M.D., M.P.H. | NY Downtown Hospital | Study Director |
| Alan Arslan, M.D. | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19939441 | Result | Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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randomized double blind intervention trial
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central pharmacy dispenses based on sealed randomization table
| Red rice bran | Dietary Supplement | this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules |
|
| one year |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |